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510(k) Data Aggregation

    K Number
    K982458
    Device Name
    VIVALLOY HR
    Manufacturer
    AB ARDENT
    Date Cleared
    1998-08-24

    (40 days)

    Product Code
    EJJ
    Regulation Number
    872.3070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VIVALLOY HR is to be used as a filling material for restoring function to teeth which have lost portions to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Single surface cavities such as Class I Two surface cavities such as MO, DO, FO, LO Three surface cavities such as MOD, FOD. Pinned onlays and half crowns. Core build-ups for cast half and full crowns. For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

    Device Description

    VIVALLOY HR is to be used as a filling material for restoring function to teeth which have lost portions to caries.

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or any study that proves the device meets specific acceptance criteria. The document is primarily a 510(k) clearance letter from the FDA for a dental filling material called VIVALLOY HR, along with its indications for use. It confirms substantial equivalence to a legally marketed predicate device but does not include details about device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and supporting studies.

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